(29 days)
The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Total Elbow Prosthesis is intended for cemented use only.
Total Elbow replacement are used to treat a number of clinical conditions such are severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Total Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.
The present Device Modification submission corresponds to :
- the addition of one ulnar longer stem with the same diameter to the previous range with the same indications for use already covered by the previous 510(k) clearance,
- the addition of the possibility to manufacture some components in an other grade of CoCr alloy, the manufacturing method is unchanged compared to the previous 510(k) clearance,
- the modification of the locking mechanism of the ulnar cap. -
This document is a 510(k) premarket notification for a medical device called the "Tornier Total Elbow Prosthesis." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've described for a typical AI/software device.
Instead, this document is focused on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary pathway for many medical devices in the US to gain market clearance. This type of submission relies on showing that the new device is as safe and effective as existing, cleared devices, rather than conducting a separate study to establish novel performance criteria directly.
Therefore, many of your requested items are not applicable to this type of regulatory submission. I will explain why each item is not present in this document:
1. A table of acceptance criteria and the reported device performance:
- Not applicable. This document establishes substantial equivalence to predicate devices, meaning its performance is considered acceptable if it is comparable to already cleared devices. It does not define new, specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) with corresponding reported performance from a dedicated study. The "performance" assessment here is generally implicit, based on material properties, design changes, and intended use being similar to predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. There is no "test set" in the context of an algorithm evaluation as this is a physical implant. The submission refers to and compares the new device with existing predicate devices based on their established safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This pertains to a physical implant, not an AI or diagnostic device that requires expert-established ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for diagnostic performance studies, not for a physical implant's regulatory submission of this nature.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. An MRMC study is relevant for AI-assisted diagnostic tools impacting human reader performance. This document is for a physical elbow implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. There is no "ground truth" as would be defined for a diagnostic or AI device. The "truth" in this context is the safety and effectiveness profile of the predicate devices.
8. The sample size for the training set:
- Not applicable. No AI/algorithm is being trained for this physical implant.
9. How the ground truth for the training set was established:
- Not applicable. No AI/algorithm is being trained, so no training set or its ground truth is mentioned.
Summary of the document's content, focusing on what is present and relevant to "proving" safety and effectiveness in this context:
The document describes a Special 510(k) submission for a Tornier Total Elbow Prosthesis. The "proof" of safety and effectiveness lies in demonstrating substantial equivalence to previously cleared devices.
Acceptance Criteria (Implicit via Substantial Equivalence):
The primary "acceptance criterion" for this 510(k) is that the modified Tornier Total Elbow Prosthesis is substantially equivalent in terms of indications for use, technological characteristics, and safety/effectiveness to predicate devices already cleared by the FDA. This means:
- It serves the same clinical purpose.
- It has similar technological characteristics (materials, design principles, etc.).
- Any differences do not raise new questions of safety or effectiveness.
Reported Device Performance (Implicit via Substantial Equivalence):
The document asserts that the Tormier Total Elbow Prosthesis "is intended to accomplish these goals" (restore elbow function, reduce pain) and that the modifications (new ulnar stem, alternative CoCr alloy, locking mechanism change) are within the scope of existing indications and do not alter fundamental performance.
Study/Evidence that Proves Acceptance Criteria:
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Predicate Device Comparison: The core of the "study" is a comparison to legally marketed predicate devices:
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Device Description and Modifications: The submission details the modified aspects:
- Addition of one ulnar longer stem (same diameter, same indications).
- Addition of possibility to manufacture some components in another grade of CoCr alloy (ISO 5832-12 or ISO 5832-4 for humeral components; ISO 5832-7 or ISO 5832-12 or ISO 5832-4 for ulnar/radial components), while maintaining an unchanged manufacturing method.
- Modification of the locking mechanism of the ulnar cap.
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Materials: The materials used are specified and conform to international standards (ISO 5832 for CoCr alloys and UHMWPE). This implies that material performance (biocompatibility, mechanical properties) is well-established and accepted.
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Indications for Use: The indications for use are explicitly stated and aligned with those of predicate devices:
- Relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic elbow disease.
- Correction of functional deformities.
- Revision procedures.
- Treatment of unmanageable fractures.
- Intended for cemented use only.
By showing that the new device is either identical or very similar in design, materials, and intended use to these already cleared devices, and that the modifications do not introduce new safety or effectiveness concerns, the FDA determines that the device is "substantially equivalent" and grants clearance. This is the "proof" within the context of a 510(k) submission for this type of device.
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.